BILL NUMBER: AB 1557	CHAPTERED  10/10/99

	CHAPTER   695
	FILED WITH SECRETARY OF STATE   OCTOBER 10, 1999
	APPROVED BY GOVERNOR   OCTOBER 6, 1999
	PASSED THE ASSEMBLY   AUGUST 26, 1999
	PASSED THE SENATE   AUGUST 24, 1999
	AMENDED IN SENATE   AUGUST 19, 1999
	AMENDED IN SENATE   JULY 14, 1999
	AMENDED IN SENATE   JUNE 23, 1999
	AMENDED IN ASSEMBLY   MAY 28, 1999
	AMENDED IN ASSEMBLY   MAY 17, 1999

INTRODUCED BY   Assembly Member Migden
   (Principal coauthor:  Assembly Member Bock)
   (Coauthors:  Assembly Members Aroner and Shelley)

                        FEBRUARY 26, 1999

   An act to amend Sections 1242, 1242.5, 1246, and 1269 of the
Business and Professions Code, and to amend Section 120580 of the
Health and Safety Code, relating to clinical laboratories.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1557, Migden.  Clinical laboratories:  unlicensed personnel.
   Existing law regulates clinical laboratories.  These provisions
require, among other things, that individuals be licensed to perform
various laboratory tests.  However, certain provisions specifically
authorize an unlicensed person employed by a licensed clinical
laboratory to perform venipuncture or skin puncture for the purpose
of withdrawing blood for test purposes, upon specific authorization
from a licensed physician and surgeon, if that unlicensed person
meets specified requirements.  Existing law also authorizes the State
Department of Health Services to authorize by regulation unlicensed
laboratory personnel to perform skin tests for specific diseases,
venipuncture, arterial puncture, or skin puncture for the purposes of
withdrawing blood or for test purposes, as specified.
   Existing law authorizes an unlicensed person employed by a public
health department as a venereal disease case investigator to perform
venipuncture or skin puncture for the purpose of withdrawing blood
for test purposes, as specified.
   This bill would require the department to adopt regulations by
January 1, 2001, for becoming a "certified phlebotomy technician,"
would require unlicensed persons employed by a clinical laboratory or
by a public health department who perform venipuncture or skin
puncture to obtain certification pursuant to these regulations to
perform the above-specified acts on and after the effective date of
those regulations, and would authorize the department to charge fees
not to exceed $25 for application and renewal of these certificates.
The bill would not require unlicensed persons employed by a clinical
laboratory who are performing these duties on the effective date of
these regulations to be certified pursuant to these regulations until
3 years after the effective date of those regulations.  The bill
would also provide that the department may adopt regulations to issue
a separate certificate to unlicensed persons employed by a clinical
laboratory who only perform skin puncture tests.
   The bill would also make related changes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 1242 of the Business and Professions Code is
amended to read:
   1242.  Any person duly licensed under the provisions of this
chapter to perform tests called for in a clinical laboratory may
perform skin tests for specific diseases, arterial puncture,
venipuncture, or skin puncture for purposes of withdrawing blood or
for clinical laboratory test purposes as defined by regulations
established by the department and upon specific authorization from
any person in accordance with the authority granted under any
provisions of law relating to the healing arts.
  SEC. 2.  Section 1242.5 of the Business and Professions Code is
amended to read:
   1242.5.  Notwithstanding paragraphs (2) and (3) of subdivision (b)
of Section 1241, the department may by regulation authorize
laboratory personnel certified pursuant to Section 1246 to perform
venipuncture, arterial puncture, or skin puncture for the purposes of
withdrawing blood or for clinical laboratory test purposes, as
defined by regulations established by the department.
  SEC. 3.  Section 1246 of the Business and Professions Code is
amended to read:
   1246.  (a) Except as provided in subdivision (b), and in Section
23158 of the Vehicle Code, an unlicensed person employed by a
licensed clinical laboratory may perform venipuncture or skin
puncture for the purpose of withdrawing blood or for clinical
laboratory test purposes upon specific authorization from a licensed
physician and surgeon provided that he or she meets both of the
following requirements:
   (1) He or she works under the supervision of a person licensed
under this chapter or of a licensed physician or surgeon or of a
licensed registered nurse.  A person licensed under this chapter, a
licensed physician or surgeon, or a registered nurse shall be
physically available to be summoned to the scene of the venipuncture
within five minutes during the performance of those procedures.
   (2) He or she has been trained by a licensed physician and surgeon
or by a clinical laboratory bioanalyst in the proper procedure to be
employed when withdrawing blood in accordance with training
requirements established by the State Department of Health Services
and has a statement signed by the instructing physician and surgeon
or by the instructing clinical laboratory bioanalyst that such
training has been successfully completed.
   (b) (1) On and after the effective date of the regulations
specified in paragraph (2), any unlicensed person employed by a
clinical laboratory performing the duties described in this section
shall possess a valid and current certification as a "certified
phlebotomy technician" issued by the department.  However, an
unlicensed person employed by a clinical laboratory to perform these
duties pursuant to subdivision (a) on that date shall comply with
this requirement within three years after the effective date of those
regulations.
   (2) The department shall adopt regulations for certification by
January 1, 2001, as a "certified phlebotomy technician" that shall
include all of the following:
   (A) The applicant shall hold a valid, current certification as a
phlebotomist issued by a national accreditation agency approved by
the department, and shall submit proof of that certification when
applying for certification pursuant to this section.
   (B) The applicant shall complete education, training, and
experience requirements as specified by regulations that shall
include, but not be limited to, the following:
   (i) At least 40 hours of didactic instruction.
   (ii) At least 40 hours of practical instruction.
   (iii) At least 50 successful venipunctures.
   However, an applicant who has been performing these duties
pursuant to subdivision (a) may be exempted from the requirements
specified in clauses (ii) and (iii), and from 20 hours of the 40
hours of didactic instruction as specified in clause (i), if he or
she has at least 1,040 hours of work experience, as specified in
regulations adopted by the department.
   It is the intent of the Legislature to permit persons performing
these duties pursuant to subdivision (a) to use educational leave
provided by their employers for purposes of meeting the requirements
of this section.
   (3) Each "certified phlebotomy technician" shall complete at least
three hours per year or six hours every two years of continuing
education or training.  The department shall consider a variety of
programs in determining the programs that meet the continuing
education or training requirement.
   (4) He or she has been found to be competent in phlebotomy by a
licensed physician and surgeon or person licensed pursuant to this
chapter.
   (5) He or she works under the supervision of a licensed physician
and surgeon, licensed registered nurse, or person licensed under this
chapter, or the designee of a licensed physician and surgeon or the
designee of a person licensed under this chapter.
   (6) The department shall adopt regulations establishing standards
for approving training programs designed to prepare applicants for
certification pursuant to this section.  The standards shall ensure
that these programs meet the state's minimum education and training
requirements for comparable programs.
   (7) The department shall adopt regulations establishing standards
for approving national accreditation agencies to administer
certification examinations and tests pursuant to this section.
   (8) The department shall charge fees for application for and
renewal of the certificate authorized by this section of no more than
twenty-five dollars ($25).
   (c) The department may adopt regulations providing for the
issuance of a certificate to an unlicensed person employed by a
clinical laboratory authorizing only the performance of skin
punctures for test purposes.
  SEC. 4.  Section 1269 of the Business and Professions Code is
amended to read:
   1269.  (a) Unlicensed laboratory personnel may perform any of the
activities identified in subdivision (b), in a licensed clinical
laboratory, under the direct and constant supervision of a physician
and surgeon, or a person licensed under this chapter other than a
trainee, upon meeting all of the following criteria:
   (1) Have earned a high school diploma, or its equivalent, as
determined by HCFA under CLIA.
   (2) Have documentation of training appropriate to ensure that the
individual has all of the following skills and abilities:
   (A) The skills required for proper specimen collection, including
patient preparation, labeling, handling, preservation or fixation,
processing or preparation, and transportation and storage of
specimens.
   (B) The skills required for assisting a licensed physician and
surgeon or personnel licensed under this chapter, other than
trainees, in a licensed clinical laboratory.
   (C) The skills required for performing preventive maintenance, and
troubleshooting.
   (D) A working knowledge of reagent stability and storage.
   (E) The skills required for assisting in the performance of
quality control procedures, and an understanding of the quality
control policies of the laboratory.
   (F) An awareness of the factors that influence test results.
   (b) The activities that may be performed are:
   (1) Biological specimen collection, including patient preparation,
labeling, handling, preservation or fixation, processing or
preparation, and transportation and storage of specimens.
   (2) Assisting a licensed physician and surgeon or personnel
licensed under this chapter, other than trainees, in a licensed
clinical laboratory.
   (3) Assisting in preventive maintenance, and troubleshooting.
   (4) Preparation and storage of reagents and culture media.
   (5) Assisting in the performance of quality control procedures.
   (c) Notwithstanding subdivision (a), unlicensed laboratory
personnel, other than a trainee, may, under the supervision and
control of a physician and surgeon or person licensed under this
chapter, perform specimen labeling, handling, preservation or
fixation, processing or preparation, transportation, and storing if
he or she meets the requirements of subparagraph (A) of paragraph (2)
of, and paragraph (1) of, subdivision (a).
   (d) Unlicensed laboratory personnel shall not do any of the
following:
   (1) Record test results, but he or she may transcribe results that
have been previously recorded, either manually by a physician and
surgeon or personnel licensed under this chapter, or automatically by
a testing instrument.
   (2) Perform any test or part thereof that involves the
quantitative measurement of the specimen or test reagent, or any
mathematical calculation relative to determining the results or the
validity of a test procedure.
   (3) Perform any phase of clinical laboratory tests or examinations
in the specialty of immunohematology beyond initial collection and
centrifugation.
   (e) When any of the following manual methods are employed, the
activities of unlicensed laboratory personnel shall be limited as
follows:
   (1) In the case of qualitative and semi-quantitative "spot,
tablet, or stick" tests, the personnel may add the test reagent to
the specimen or vice versa, but the results must be read by a
physician and surgeon or person licensed under this chapter.
   (2) In the case of microbiological tests the unlicensed laboratory
personnel may make primary inoculations of test material onto
appropriate culture media, stain slide preparations for microscopic
examination, and subculture from liquid media.
   (f) When any of the following mechanical or electronic instruments
are employed, unlicensed laboratory personnel shall not perform any
of the following activities:
   (1) Standardizing or calibrating the instrument or assessing its
performance by monitoring results of appropriate standards and
control.
   (2) Reading or recording test results, except that the personnel
may transcribe results that have been previously recorded
automatically by a testing instrument.
   (3) Quantitatively measuring any sample or reagents unless done
automatically by the instrument in the course of its normal operation
or by the use of previously calibrated and approved automatic
syringes or other dispensers.
  SEC. 5.  Section 120580 of the Health and Safety Code is amended to
read:
   120580.  Notwithstanding any other provision of law, a person
employed by a public health department may perform venipuncture or
skin puncture for the purpose of withdrawing blood for test purposes,
upon specific authorization from a licensed physician and surgeon,
even though he or she is not otherwise licensed to withdraw blood;
provided that the person meets all of the following requirements:
   (1) He or she works under the direction of a licensed physician
and surgeon.
   (2) He or she has been trained by a licensed physician and surgeon
or by a licensed clinical laboratory scientist or bioanalyst in the
proper procedures to be employed when withdrawing blood, in
accordance with training requirements established by the  department,
and has a statement signed by the instructing physician and surgeon
that the training has been successfully completed.
   (b) Any person employed by a public health department to perform
venipuncture or skin puncture shall hold a valid and current
certification after the effective date of the regulations adopted
pursuant to Section 1246 of the Business and Professions Code.
